EN
Myo Kinisi van Steeper, distributeur Loth Fabenim B.V.
Myo Kinisi Technical Manual
34
Quality Assurance
25
Steeper/SteeperUSA operate a quality management system that fully complies with
the requirements of ISO 13485:2016. This certifies that Steeper/SteeperUSA meet
the appropriate international quality standards for the design, manufacture and
supply of prosthetic products.
Steeper is registered with both the Medicines and Healthcare Regulatory Authority
in the UK, and the Food and Drugs Administration of the United States Government
for the manufacture and supply of prosthetic and orthotic products.
MHRA Registration N°: 0000006617
FDA Registration N°: 9612243
Model N°: RP628
This Device complies with the requirements of the Medical Device Regulations MDR
2017/745.
The design and manufacture of Steeper equipment and components are subject
to a policy of continuous reappraisal. The company, therefore, reserves the right to
introduce changes and withdraw products without notice.
This device is CE marked to confirm the device is compliant with EU Legislation and
meets the EU safety, health or environmental requirements. The CE mark may be
applied on packaging, accompanying literature or an enclosure, rather than the
product itself.
This device is UKCA marked to confirm the device is compliant with the legislation
of Great Britain and meets the health, safety or environmental requirements. The
UKCA mark may be applied on packaging, accompanying literature or an enclosure,
rather than the product itself.
